An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD).

It had 1 arm (groups): Oxytocin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to people of any sex aged from 11 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female outpatients ages 11-17 years. DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL). At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD. Subjects and their parent/guardian must be considered reliable reporters. Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: IQ \<85; total lack of spoken language; DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-10 with completion listed for 2016-02-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in ASD Symptoms Social Responsiveness Scales 2 (SRS-2) Scales From Baseline to Week 8 (time frame: Week-8).

What This Means in Plain Language

Put simply, this is a not phased trial of Oxytocin in 8 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.